Table 1.
Characteristics of patients and their disease burden, according to treatment groups and baseline corticosteroid use.
| Patients with baseline corticosteroid use | Patients without baseline corticosteroid use | Enzalutamide-treated patient with vs. without baseline corticosteroid use | Placebo-treated patient with vs. without baseline corticosteroid us | |||||
|---|---|---|---|---|---|---|---|---|
| Enzalutamide n = 241 (30.1%a) |
Placebo n = 119 (29.8%b) |
P value | Enzalutamide n = 559 (69.9%a) |
Placebo n = 280 (70.2%b) |
P value | P value | P value | |
| Baseline characteristics | ||||||||
| Age | ||||||||
| Mean, years | 68.8 | 67.5 | 0.156 | 68.8 | 69.1 | 0.612 | 1.00 | 0.082 |
| % ≥75 years | 26% | 20% | 0.245 | 25% | 29% | 0.205 | 0.715 | 0.080 |
| Gleason score (mean) | 7.7 | 7.8 | 0.476 | 7.5 | 7.5 | 1 | 0.056 | 0.033 |
| ECOG performance status = 2 | 14.5% | 4.2% | 0.003 | 6.3% | 9.6% | 0.078 | <0.001 | 0.067 |
| BPI ≥4 on question 3 c | 31.5% | 36.1% | 0.383 | 26.8% | 25.7% | 0.729 | 0.175 | 0.036 |
| Prior musculoskeletal and connective tissue disorders | 68.5% | 64.7% | - | 66.4% | 60.4% | - | - | - |
| Duration of corticosteroid use (mean months, range) | 8.9 (0.0–128.3) | 9.8 (0.0–44.2) | - | - | - | - | - | - |
| Disease burden | ||||||||
| Mean PSA (ng/mL) | 582.6 | 405.8 | 0.104 | 343.6 | 382.4 | 0.596 | <0.001 | 0.847 |
| Mean hemoglobin (g/L) | 116.2 | 117.4 | 0.517 | 120.4 | 120.4 | 1 | <0.001 | 0.090 |
| % abnormal (<125 g/L) | 68.3% | 61.3% | 0.188 | 57.1% | 57.5% | 0.905 | 0.003 | 0.476 |
| Mean alkaline phosphatase (U/L) | 295.5 | 342.5 | 0.428 | 206.2 | 191.6 | 0.527 | 0.002 | 0.001 |
| % abnormal (>125 U/L) | 56.4% | 47.9% | 0.127 | 41.9% | 42.1% | 0.938 | <0.001 | 0.289 |
| Mean LDH (U/L) | 316.0 | 314.5 | 0.954 | 252.5 | 249.7 | 0.880 | <0.001 | <0.001 |
| % abnormal (>234 U/L) | 53.1% | 52.5% | 0.919 | 31.3% | 35.5% | 0.224 | 0 | 0.002 |
| Mean albumin (g/L) | 36.1 | 37.0 | 0.047 | 38.1 | 37.7 | 0.175 | 0 | 0.128 |
| % abnormal <33 (g/L) | 19.1% | 13.4% | 0.182 | 9.3% | 11.2% | 0.399 | <0.001 | 0.517 |
| Any lab abnormality % abnormal | 85.5% | 84.9% | 0.879 | 71.9% | 71.1% | 0.799 | 0 | 0.004 |
| Visceral disease at screening | 29.0% | 18.5% | 0.031 | 22.5% | 21.4% | 0.715 | 0.050 | 0.506 |
| >20 bone metastases at screening | 49.0% | 47.1% | 0.734 | 32.9% | 33.9% | 0.769 | 0 | 0.013 |
| Months from initial diagnosis (mean) | 80.7 | 71.3 | - | 88.4 | 86.4 | - | - | - |
| Baseline opioid use = Yes | 55.6% | 61.3% | 0.230 | 39.0% | 47.1% | 0.024 | 0 | 0.009 |
BPI, Brief Pain Inventory; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; PSA, prostate-specific antigen.
a
Percent of enzalutamide patients.
b
Percent of placebo patients.
c
BPI Short Form Question 3 measures pain on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
Significant P values are indicated in bold.